U.S. patent application number 14/199901 was filed with the patent office on 2014-08-21 for catheters and related devices for forming passageways between blood vessels or other anatomical structures.
This patent application is currently assigned to Medtronic Vascular, Inc.. The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Philip Christopher Evard, Christopher Flaherty, John Thomas Garibotto, Patrick Edward Macaulay, Timothy R. Machold, Joshua Makower, Alan Robert Selfridge, Margaret W. Tumas, Jason Brian Whitt.
Application Number | 20140236207 14/199901 |
Document ID | / |
Family ID | 25274080 |
Filed Date | 2014-08-21 |
United States Patent
Application |
20140236207 |
Kind Code |
A1 |
Makower; Joshua ; et
al. |
August 21, 2014 |
Catheters and Related Devices for Forming Passageways Between Blood
Vessels or Other Anatomical Structures
Abstract
The inventions described in this patent application include i) a
torqueable introducer sheath which is useable in conjunction with a
transvascular passageway forming catheter to effect precise
rotational control of the catheter; ii) an anchorable guide
catheter which is useable in conjunction with an intravascular
imaging catheter and a transvascular passageway-forming catheter to
effect precise positioning and aiming of the passageway-forming
catheter; iii) a passageway forming catheter having a torqueable
proximal portion to facilitate precise rotational positioning of
the distal portion of the catheter; iv) a deflectable-tipped
passageway forming catheter, v) various markers and other apparatus
useable in conjunction with any of the passageway-forming catheters
to facilitate precise positioning and aiming of the catheter, and
vi) an apparatus which may be formed within a catheter to prevent a
member, apparatus of flow of material from being inadvertently
advanced through a lumen of the catheter.
Inventors: |
Makower; Joshua; (Los Altos,
CA) ; Flaherty; Christopher; (Los Altos, CA) ;
Machold; Timothy R.; (Moss Beach, CA) ; Whitt; Jason
Brian; (San Francisco, CA) ; Evard; Philip
Christopher; (Palo Alto, CA) ; Macaulay; Patrick
Edward; (San Jose, CA) ; Garibotto; John Thomas;
(Newark, CA) ; Tumas; Margaret W.; (Orinda,
CA) ; Selfridge; Alan Robert; (Los Gatos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Assignee: |
Medtronic Vascular, Inc.
Santa Rosa
CA
|
Family ID: |
25274080 |
Appl. No.: |
14/199901 |
Filed: |
March 6, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12634850 |
Dec 10, 2009 |
8753366 |
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14199901 |
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|
09912122 |
Jul 24, 2001 |
7648517 |
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12634850 |
|
|
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|
08837294 |
Apr 11, 1997 |
6302875 |
|
|
09912122 |
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|
08730327 |
Oct 11, 1996 |
6190353 |
|
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08837294 |
|
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60010614 |
Feb 2, 1996 |
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60005164 |
Oct 13, 1995 |
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Current U.S.
Class: |
606/185 |
Current CPC
Class: |
A61B 8/445 20130101;
A61B 2017/00247 20130101; A61M 25/0147 20130101; A61B 18/1492
20130101; A61B 90/40 20160201; A61B 2017/00504 20130101; A61B
2017/22072 20130101; A61B 2017/12127 20130101; A61B 17/12136
20130101; A61B 2017/22069 20130101; A61M 2025/009 20130101; A61B
2018/00392 20130101; A61M 25/0141 20130101; A61F 2/2493 20130101;
A61M 25/0084 20130101; A61M 2025/1052 20130101; A61B 2017/00252
20130101; A61M 29/00 20130101; A61B 2090/3925 20160201; A61B
2017/003 20130101; A61B 17/00491 20130101; A61B 18/00 20130101;
A61B 2017/1107 20130101; A61B 2017/1139 20130101; A61B 17/0643
20130101; A61M 29/02 20130101; A61B 2090/0811 20160201; A61B
2017/306 20130101; A61B 2017/22067 20130101; A61B 17/12045
20130101; A61B 17/12022 20130101; A61B 2017/22068 20130101; A61B
8/4488 20130101; A61B 2090/378 20160201; A61B 17/3439 20130101;
A61B 17/12109 20130101; A61B 2090/3929 20160201; A61B 90/39
20160201; A61B 2017/00243 20130101; A61B 2018/1425 20130101; A61B
17/3207 20130101; A61M 25/0155 20130101; A61B 17/3478 20130101;
A61B 18/1477 20130101; A61M 2025/0076 20130101; A61B 17/11
20130101; A61B 2017/347 20130101; A61B 17/3417 20130101; A61B 8/12
20130101; A61F 2002/30079 20130101; A61F 2210/009 20130101 |
Class at
Publication: |
606/185 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. (canceled)
2. A catheter device, comprising: an elongate flexible catheter
having a distal portion insertable into a blood vessel of a human
subject; a tissue penetrating member configured to extend in a
first direction from the distal portion of the catheter; a balloon
which, when inflated, extends from the distal portion of the
catheter in a second direction opposite the first direction; and a
lumen extending through the catheter and useable for inflation and
deflation of the balloon.
3. The catheter device of claim 2 wherein the tissue penetrating
member comprises a hollow needle.
4. The catheter device of claim 2 wherein the tissue penetrating
member is configured to penetrate a wall of the blood vessel when
the balloon is at least partially inflated.
5. The catheter device of claim 2, further comprising rotational
marking indicia at the distal portion of the catheter, wherein the
rotational marking indicia are useable for rotational adjustment of
the distal potion of the catheter within the blood vessel to aim
the tissue penetrating member toward an intended target location
prior to inflation of the balloon.
6. The catheter device of claim 5 wherein the rotational marking
indicia comprise radiographic markings.
7. The catheter device of claim 6 wherein the radiographic markings
are imageable by an extracorporeally positioned imaging
apparatus.
8. The catheter device of claim 2, further comprising a balloon
exit port in the distal portion of the catheter at a location
diametrically opposite a location from which the tissue penetrating
member extends, and wherein, when inflated, the balloon protrudes
out of the balloon exit port in the second direction.
9. The catheter device of claim 2 wherein the catheter extends
along a catheter axis, and wherein the first direction is lateral
to the catheter axis.
10. The catheter device of claim 2 wherein the tissue penetrating
member comprises an advancable member.
11. A method for treating a human patient, the method comprising:
positioning a distal portion of an elongate flexible catheter
within a blood vessel of the patient, wherein the catheter
includes-- a tissue penetrating member configured to extend in a
first direction from the distal portion of the catheter toward a
perivascular target location outside of the blood vessel; and an
inflatable pressure exerting member transformable between a
low-profile delivery state and an inflated state, wherein, in the
inflated state, the pressure exerting member extends from the
distal portion of the catheter in a second direction opposite the
first direction; inflating the pressure exerting member via
inflation fluid passed through a lumen of the catheter; and
advancing the tissue penetrating member toward the perivascular
target location simultaneous with inflation of the pressure
exerting member.
12. The method of claim 11 wherein the tissue penetrating member
comprises a hollow needle, and wherein the method further comprises
delivering a substance or apparatus through the hollow needle to
the perivascular target location.
13. The method of claim 11 wherein the catheter further comprises
rotational marking indicia, and wherein the method further
comprises using the rotational marking indicia to rotationally
adjust the distal portion of the catheter within the blood vessel
to aim the tissue penetrating member toward an intended target
location prior to inflating the pressure exerting member.
14. The method of claim 13 wherein the rotational marking indicia
comprises radiographic markings, and wherein using the rotational
marking indicia comprises imaging the radiographic markings with an
imaging apparatus.
15. The method of claim 14 wherein the imaging apparatus is located
outside of the patient's body.
16. The method of claim 11 wherein the distal portion of the
catheter comprises a pressure exerting member exit port at a
location diametrically opposite a location from which the tissue
penetrating member extends, and wherein inflation of the pressure
exerting member causes the pressure exerting member to protrude
from the exit port in the second direction.
17. The method of claim 11 wherein inflating the pressure exerting
member comprises inflating the pressure exerting member such that
the pressure exerting member extends in the second direction and
contacts a wall of the blood vessel thereby pushing the tissue
penetrating member in the first direction opposite the second
direction and anchoring the catheter in place within the blood
vessel.
18. The method of claim 11 wherein advancing the tissue penetrating
member comprises sliding the tissue penetrating member through at
least a portion of the catheter.
Description
RELATED APPLICATION
[0001] This patent application is a continuation of copending U.S.
patent application Ser. No. 12/634,850 filed Dec. 9, 2009 which is
a division of Ser. No. 09/912,122 filed Jul. 24, 2001 and issued as
U.S. Pat. No. 7,648,517, which is a division of Ser. No. 08/837,294
filed Apr. 11, 1997 and issued as U.S. Pat. No. 6,302,875, which is
a continuation-in-part of U.S. patent applications Ser. No.
08/730,327 filed Oct. 11, 1996 and Ser. No. 08/730,496 filed Oct.
11, 1996 and issued as U.S. Pat. No. 6,190,353 which claims
priority to U.S. Provisional Patent Applications No. 60/010,614
filed Feb. 2, 1996 and 60/005,164 filed Oct. 13, 1995, the entire
disclosures of which are expressly incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods, and more particularly to catheters, catheter
positioning/aiming systems, and related methods for forming
interstitial passageways (e.g., interstitial tunnels) between two
or more adjacently situated blood vessels or other anatomical
structures.
BACKGROUND OF THE INVENTION
[0003] Applicant has invented novel methods for bypassing
obstructions in arteries and for performing other transvascular
medical procedures, wherein a catheter device is inserted
transluminally into the blood vessel or other luminal anatomical
structure and a tissue-penetrating element (e.g., a puncturing
member or a flow of energy) is passed out of the catheter, through
the wall of the blood vessel or other anatomical structure in which
the catheter is positioned, and into a second blood vessel or other
target anatomical structure. In this manner one or more
interstitial passageways is/are formed from the blood vessel or
other luminal structure in which the catheter is positioned, to a
second blood vessel or other target tissue. These transvascular
procedures, and certain passageway forming catheters which are
useable to perform these procedures, have previously been described
in U.S. patent applications Ser. No. 08/730,327 entitled METHODS
AND APPARATUS FOR BYPASSING ARTERIAL OBSTRUCTIONS AND/OR PERFORMING
OTHER TRANSVASCULAR PROCEDURES, filed on Oct. 11, 1996 and Ser. No.
08/730,496 entitled, A DEVICE, SYSTEM AND METHOD FOR INTERSTITIAL
TRANSVASCULAR INTERVENTION, filed Oct. 11, 1996.
[0004] In performing the above-summarized transvascular procedures,
it is important that the passageway-forming catheter be properly
positioned and oriented within the body in the order to ensure that
the tissue-penetrating element will form the desired interstitial
passageway, at the desired location. If the catheter is improperly
positioned or improperly oriented, the resultant passageway(s) may
fail to perform their intended function (e.g., to channel blood
from one location to another) or the tissue penetrating element of
the catheter may perforate or traumatize tissue(s) other than those
intended to be canalized.
[0005] In many of the passageway-forming catheters devised by
applicant, it is necessary to precisely control the rotational
orientation of the catheter in order to accomplish the desired
aiming of the tissue-penetrating element. However, when the
passageway-forming catheter is formed of relatively small diameter,
thin-walled polymeric material capable of navigating small,
tortuous blood vessels, the catheter shaft may lack sufficient
structural integrity to efficiently transfer torque from the
proximal end of the catheter to the distal end thereof. Such
diminished torque transfer of the catheter shaft can prevent or
interfere with the precise rotational orientation and positioning
of the distal portion of the catheter prior to formation of the
extravascular passageway.
[0006] Additionally, to facilitate the use of any on-board imaging
system (e.g., an intravascular ultrasound system inserted or built
into the passageway-forming catheter) or any separate
intracorporeal or extracorporeal imaging services intended to
assist in the precise aiming of the tissue-penetrating element, it
is desirable for the tissue-penetrating catheter to be provided
with appropriate markers or other indicia to enable the operator to
utilize to discern the present rotational orientation and position
of the catheter and the projected path of the tissue-penetrating
element.
[0007] Thus, there remains a need in the art for further
development and modification of applicant's previously described
passageway-forming catheter devices so as to provide for i)
improved torque transfer to the distal portion of the catheter and
ii) precise rotational orientation and aiming of the catheter prior
to deployment of the tissue penetrating element.
SUMMARY OF THE INVENTION
[0008] The inventions described in this patent application include
i) a torqueable introducer sheath which is useable in conjunction
with a transvascular passageway forming catheter to effect precise
rotational control of the catheter; ii) an anchorable guide
catheter which is useable in conjunction with an intravascular
imaging catheter and a transvascular passageway-forming catheter to
effect precise positioning and aiming of the passageway-forming
catheter; iii) a passageway forming catheter having a torqueable
proximal portion to facilitate precise rotational positioning of
the distal portion of the catheter; iv) a deflectable-tipped
passageway forming catheter, v) various markers and other apparatus
useable in conjunction with any of the passageway-forming catheters
to facilitate precise positioning and aiming of the catheter, and
vi) an apparatus which may be formed within a catheter to prevent a
member, apparatus of flow of material from being inadvertently
advanced through a lumen of the catheter.
[0009] Additional details and objects of each of the
above-summarized inventions will become apparent to those skilled
in the art upon reading and understanding of the following detailed
descriptions of preferred embodiments and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of a torqueable sheath through
which a passageway-forming catheter of the present invention may be
inserted, and which may be used to facilitate subsequent rotational
positioning of the distal portion of the passageway-forming
catheter.
[0011] FIG. 1a is a cut-away perspective view of the distal end of
the torqueable sheath of FIG. 1, and shown in phantom lines the
preferred operative positioning of a passageway-forming catheter
within such torqueable sheath.
[0012] FIG. 1b is a partial cut-away perspective view of portion 1b
of FIG. 1, showing the braided wire layer formed within the
proximal portion of the torqueable sheath.
[0013] FIG. 1c is a cross-sectional view through line 1c-1c of FIG.
1.
[0014] FIG. 1d is a cross-sectional view through line 1d-1d of FIG.
1.
[0015] FIG. 1e is a cross-sectional view through line 1e-1e of FIG.
1.
[0016] FIG. 1f is a perspective view of a typical
passageway-forming catheter of Applicant's invention, as previously
described in U.S. patent application Ser. No. 08/730,327, entitled
METHODS AND APPARATUS FOR BYPASSING ARTERIAL OBSTRUCTIONS AND/OR
PERFORMING OTHER TRANSVASCULAR PROCEDURES filed on Oct. 11,
1996.
[0017] FIG. 1g is a cross-sectional view through line 1g-1g of FIG.
1f, and additional showing in phantom lines the preferred operative
positioning of a torqueable sheath of the present invention
relative to that portion of the passageway-forming catheter.
[0018] FIG. 2 is a perspective view of a guide catheter of the
present invention having an anchoring balloon formed on the distal
end thereof.
[0019] FIG. 2a is a partial longitudinal sectional view through
line 2a-2a of the guide catheter of FIG. 2, showing an
intravascular ultrasound device operatively inserted into the guide
catheter.
[0020] FIG. 2b is a cross-sectional view through line 2b-2b of the
guide catheter FIG. 2 having an intravascular ultrasound catheter
operatively inserted therethrough.
[0021] FIG. 2c is a cross-sectional view through line 2c-2c of FIG.
2a.
[0022] FIG. 2a' is a partial longitudinal sectional view through
line 2a-2a of the guide catheter of FIG. 2, showing a
passageway-forming catheter of the present invention operatively
inserted into the guide catheter.
[0023] FIG. 2b' is a cross sectional view through line 2b-2b of the
guide catheter of FIG. 2 having a passageway-forming catheter of
the present invention operatively inserted therethrough.
[0024] FIG. 2c' is a cross-sectional view through line 2c'-2c' of
FIG. 2a'.
[0025] FIG. 3 is a perspective view of the passageway forming
catheter of the present invention which is useable in conjunction
with the guide catheter shown in FIGS. 22c'.
[0026] FIG. 3a is a perspective view of portion 3a of FIG. 3.
[0027] FIG. 3b is a longitudinal sectional view through line 3b-3b
of FIG. 3a.
[0028] FIG. 3c is a cross-sectional view through line 3c-3c of FIG.
3.
[0029] FIG. 3d is a cross-sectional view through line 3d-3d of FIG.
3.
[0030] FIG. 4a is a perspective view of a torqueable
passageway-forming catheter device of the present invention.
[0031] FIG. 4b is a cross-sectional view through line 4b-4b of FIG.
4a.
[0032] FIG. 4c is a cross-sectional view through line 4c-4c of FIG.
4a.
[0033] FIG. 4d is a perspective view of the distal portion of a
passageway-forming catheter of the present invention incorporating
a first marker thereon.
[0034] FIG. 4e is a perspective view of the distal portion of a
passageway forming catheter of the present invention incorporating
a second marker thereon.
[0035] FIG. 4f is a perspective view of the distal portion of a
passageway forming catheter of the present invention incorporating
a third marker thereon.
[0036] FIG. 4g is a longitudinal sectional view of the distal
portion of a passageway-forming catheter having a fourth marker of
the present invention formed thereon.
[0037] FIG. 4h is a longitudinal section view of the distal portion
of a passageway forming catheter having a fifth marker formed
thereon.
[0038] FIG. 4h' is a longitudinal sectional view of the passageway
forming catheter of FIG. 4h wherein the marker has been advanced to
its operative position by insertion of an IVUS catheter through one
lumen of the passageway-forming catheter.
[0039] FIG. 4i is a perspective view of the distal portion of a
passageway forming catheter having a sixth marker formed
thereon.
[0040] FIG. 4i' is a perspective view of the distal portion of a
passageway forming catheter having a variation of the sixth marker
of FIG. 4i formed thereon.
[0041] FIG. 4j is an elevational view of the distal portion of a
passageway forming catheter having a seventh marker formed
thereon.
[0042] FIG. 4j' is an elevational view of the distal portion of the
passageway catheter of FIG. 4j wherein the seventh marker has been
advanced to an operative position by insertion of an IVUS catheter
through one lumen of the passageway forming catheter.
[0043] FIG. 4k is a longitudinal sectional view of the distal
portion of a passageway forming catheter wherein i) a
reduced-diameter guidewire lumen has been formed to permit a
guidewire to be temporarily advanced into such guidewire lumen to
act as a marker to facilitate precise rotational positioning of the
catheter, and ii) an ultrasound chip has been mounted on the
catheter adjacent the outlet opening for the tissue penetrating
element so as to cause ultrasonic vibration and enhanced
imageability of the tissue penetrating element when it is deployed
out of the opening.
[0044] FIG. 4I is an exploded perspective view of a modified
passageway-forming catheter, and a modified phased-array IVUS
catheter useable in conjunction therewith to effect precise
rotational positioning of the passageway-forming catheter.
[0045] FIG. 4I' is a schematic diagram of one type of system which
may be utilized to electronically mark or differentiate the image
received from a single crystal on the phased array imaging catheter
of FIG. 4I.
[0046] FIG. 4m is a perspective view of the distal portion of a
passageway forming catheter having an eighth marker formed
thereon.
[0047] FIG. 4m' is an elevational view of the distal portion of a
passageway forming catheter having a variant of the eighth marker
of FIG. 4m formed thereon.
[0048] FIG. 5 is a longitudinal sectional view of an adjacent
artery and vein, showing an energy-emitting/receiving guidance and
positioning system of the present invention which is useable to
effect precise positioning and rotational orientation of the
passageway-forming catheter.
[0049] FIG. 5a is a partial longitudinal sectional view of a
passageway-forming catheter of the present invention having an
alternative aiming/positioning system formed thereon, such system
comprising an active (emitting) component and a passage (receiving)
component.
[0050] FIG. 5b is a partial longitudinal sectional view of another
passageway-forming catheter of the present invention which
incorporates another aiming/positioning system thereon, such system
comprising an active (e.g., emitting) component mounted on the body
of the catheter and an imaging catheter component (e.g., an IVUS
catheter) advanceable through an imaging catheter lumen of the
passageway-forming catheter to image the target tissue after the
target tissue has been affected by energy received from the active
(emitting) component.
[0051] FIG. 5c is a partial longitudinal sectional view of another
passageway forming catheter of the present invention having an
alternative aiming/positioning system wherein the tissue
penetrating element of the catheter is an elongate member having a
sensor mounted thereon for sensing the location of the target
tissue.
[0052] FIG. 5d is a partial longitudinal sectional view of another
passageway forming catheter of the present invention (having an
alternative aiming/positioning system wherein an active (e.g.,
emitting) component is mounted in specific relation to the outlet
port for the tissue-penetrating element, and is adapted to emit a
signal to an imaging component (e.g., IVUS catheter) to accentuate
the location of the outlet port and facilitate aiming of the
catheter by use of the imaging device.
[0053] FIG. 5e is a schematic diagram of one type of system which
may be utilized to peak a signal received from the passive (e.g.,
receiving) component of an aiming/positioning system of FIGS. 5-5c
hereabove.
[0054] FIG. 6 is a schematic showing of the manner in which an
extracorporeal imaging apparatus is useable in conjunction with a
marking scheme formed on a passageway-forming catheter of the
present invention, to effect precise positioning and rotational
orientation of the passageway-forming catheter.
[0055] FIG. 6a is a showing of a first marking scheme useable with
the extracorporeal imaging system of FIG. 6.
[0056] FIG. 6b is a showing of a second marking scheme useable with
the extracorporeal imaging system of FIG. 6.
[0057] FIG. 6c is a showing of a third marking scheme useable with
the extracorporeal imaging system of FIG. 6.
[0058] FIG. 7 is a perspective view of a deflectable-tipped
passageway forming catheter system of the present invention which
comprises a) a deflectable tipped catheter; b) an imaging component
which is advanceable through the deflectable-tipped catheter and c)
a tissue-penetrating component which is passable through the
deflectable-tipped catheter.
[0059] FIG. 7a is a longitudinal sectional view of the handpiece
portion of the deflectable tipped portion of FIG. 7.
[0060] FIG. 7b is a longitudinal sectional view of the distal
portion of the deflectable-tipped catheter of FIG. 7.
[0061] FIG. 8 is a longitudinal sectional view of another
passageway-forming catheter which incorporates apparatus for
preventing deployment of the tissue-penetrating element.
[0062] FIG. 8' is a longitudinal sectional view of another
passageway-forming catheter which incorporates apparatus for
preventing deployment of the tissue-penetrating element and for
stabilizing the catheter within a luminal anatomical structure,
wherein such apparatus is in an initial configuration whereby the
lumen is blocked and the catheter is unstabilized.
[0063] FIG. 8'' is a longitudinal sectional view of another
passageway-forming catheter which incorporates apparatus for
preventing deployment of the tissue-penetrating element and for
stabilizing the catheter within a luminal anatomical structure,
wherein such apparatus is in an operative configuration wherein the
lumen is open and the catheter is stabilized.
DETAILED DESCRIPTIONS PREFERRED EMBODIMENTS
[0064] The following detailed description and the accompanying
drawings are provided for the purpose of describing and
illustrating presently preferred embodiments of the invention only,
and are not intended to limit the scope of the invention in any
way.
[0065] It is to be appreciated that the individual elements and
components of each of the embodiments described herebelow may be
individually or collectively incorporated into each of the other
embodiments capable of receiving or incorporating such element(s)
or component(s), and no effort has been made to exhaustively
describe all possible permutations and combinations of the
inventive elements and components described herein.
[0066] i. Torgueable Introducer Sheath
[0067] Referring specifically to FIGS. 1-1g, the present invention
includes a torqueable introducer sheath 10 comprising an elongate
pliable tubular sheath body 12 having a proximal end PE and a
distal end DE. The tubular sheath body 12 comprises a proximal
segment 14, a medial segment 16 and a distal segment 18. A hollow
lumen 20 extends longitudinally through the tubular sheath body 12,
such hollow lumen 20 being defined by an inner luminal surface 22.
A proximal hand piece or connector assembly 24 may be mounted on
the proximal end PE of the sheath body 12 to facilitate
manipulation of the proximal end PE of the sheath body 12 and to
receive and register against the hand piece 26 of any catheter
which is inserted through the torqueable introducer sheath 10.
[0068] A tubular catheter engaging member 28 is formed or mounted
within the lumen 20 of the distal segment 18 of the tubular sheath
body 12. Such tubular catheter engaging member 28 has a lumen 30
which extends longitudinally therethrough. The lumen 30 may be of
any non-cylindrical or nonuniform configuration, such as "pair
shape" or "egg-shape," whereby the luminal surface or a portion
thereof will engage and prevent rotation of the catheter inserted
through the sheath. An example of a generally oval shaped lumen is
shown in FIG. 1a.
[0069] A plurality of elongate reinforcement members 32, formed of
wire, fibers or other suitable material, are disposed within the
proximal and medial segments 14, 16 of the tubular sheath body 12.
These reinforcement members 32 may be helically wound about the
lumen 20 of the sheath body 12 to form an overlapping braid
structure 34. Other structures, such as a coil structure, may also
be used. In particular, such overlapping braid structure 34 may
comprise two groups of individual elongate members 32 helically
wound in opposite phase about the longitudinal axis LA of the
tubular introducer sheath body 12, and at cross over points of such
groups of elongate members 32, the individual elongate members 32
of one group will be alternately passed over and under the
individual elongate members 32 of the other group, so as to provide
a braid structure 34 which will impart enhanced structural
integrity and torque transfer to the proximal 14 and medial 16
segments of the tubular sheath body 12. In some embodiments, the
distal segment 18 may also be provided with the elongate members 32
and/or braided structure.
[0070] In embodiment of this sheath intended for coronary
application, the individual elongate members 32 may preferably be
formed of stainless steel of 0.001-0.005 inch diameter. Each group
of elongate members 32 may consist of eight such stainless steel
wire members in substantially parallel side-by-side relation to one
another. The first and second groups of elongate members 32 will be
helically wound about a tubular inner liner 36, in opposite phase
such that the first and second groups of elongate members will
repeatedly cross over each other. At locations whereat the groups
of elongate members 32 cross over each other, each individual
elongate member 32 of each group may be alternately threaded over
and under the individual elongate members 32 of the other group, so
as to provide an interwoven, braided structure 34 which will impart
enhanced torqueability to the tubular sheath body 12. A tubular
outer skin 15 is then formed over the wire braid structure 34 such
that the wire braid structure 34 is captured or located between the
tubular outer skin 15 and the tubular core member 36, as shown.
[0071] In at least some applications it may desirable to impart
regionalized differences in rigidity or hardness to the proximal
and medial segments 14, 16 of the tubular sheath body 12. In this
manner, the outer skin 15 of the proximal portion 14 may be formed
of material which is more rigid or greater in hardness than that of
the outer skin 15 of the medial portion 16. For example, the outer
skin 15 of the proximal portion 14 may be formed of thermoplastic,
elastin (e.g., Pebax, polyurethane, silicone, polyester) or
thermoset elastomer (e.g., polyurethane or flexibly epoxy) (e.g.,
Pebax) having a Shore D hardness of 60-72 while the outer skin 15
of the medial portion 16 may be formed of polymeric material (e.g.,
pebax) having a lesser hardness, such as a 40-60 Shore D hardness
on the shore D scale. The outer skin 15 of the distal portion 18
may preferably have a Shore D hardness in the range of 30-40. The
relative lengths and hardness of the inner liner 36 and outer skin
15 may be varied to adjust the overall stiffness of the catheter
and the locations of the transition areas between the proximal 14,
medial 16 and distal 18 segments of the sheath 10.
[0072] In the preferred embodiment, shown in the drawings, the
inner liner is formed of polytetrafluoroethylene (PTFE) of
consistent hardness from the proximal end PE to the distal end DE
of the tubular sheath body 12.
[0073] With reference to FIGS. 1f-1g, one type of
passageway-forming catheter 40 which is useable in conjunction with
the torqueable sheath 10 comprises an elongate pliable catheter 40
having an irregular cross sectional configuration defining an upper
portion 42 through which a tissue-penetrating element 46 may pass
and a lower portion 44 through which an imaging catheter (e.g., an
IVUS catheter) may pass.
[0074] A tissue-penetrating element 46 of the type previously
described in U.S. patent application Ser. No. 08/730,327 is
advanceable out of the distal end DE of the upper catheter portion
42 such that the tissue penetrating element 46 will diverge
laterally from the longitudinal axis LA of the catheter device 40.
In this manner, the tissue-penetrating element 46 will pass through
the wall of a blood vessel wherein the distal portion of the
catheter device 40 is positioned so as to create an extravascular
passageway extending from the blood vessel to another blood vessel
or other extravascular target location.
[0075] As shown in FIG. 1g, when the catheter 40 is advanced
through the torqueable introducer sheath 10, the upper portion 42
of the catheter body will engage the smaller diameter side of the
lumen 30 of the catheter engagement member 28, while the relatively
large diameter lower catheter portion 44 will engage the opposite
end of such lumen 30, and the passageway-forming catheter 40 will
be thereby prevented by the catheter engaging insert 28 from
rotatably moving relative to the tubular body 12 of the sheath 10.
In this manner, the operator may manually grasp the proximal
connector 24 and may apply rotational force to the proximal
connector 24, such that the rotational force will be transmitted
through the tubular sheath body 12 so as to cause the distal
segment 18 of the tubular sheath body 12 to rotate in a
substantially one to one (1:1) relation to the proximal connector
24. In this manner, the torqueable introducer sheath 10 will cause
the catheter 40 which has been inserted through the sheath 10 to
rotate in conjunction with the sheath 10, irrespective of whether
the body of the catheter 40 has sufficient structural integrity to
be capable of transmitting torque from its proximal end to its
distal end. This construction allows the use of a
passageway-forming catheter 40 which is of relatively small
diameter and formed of pliable or subtle material, while the
torqueable sheath 10 may be of stronger and less pliable material
capable of transmitting torque and acting as guide for insertion of
the catheter 40. Additionally, the catheter engaging insert 28 may
be positioned at or near the distal end of the sheath 10 so as to
transmit torque to the catheter 40 at a location at or near its
distal tip, thereby eliminating torque or rotational stress on the
majority of the catheter shaft and eliminating the potential for
kinking or buckling of the small diameter, pliable catheter body.
In this manner, the use of the sheath 10 of the present invention
in conjunction with the catheter 40 provides for the maintenance of
precise rotational control of the distal portion of the catheter
40.
[0076] ii. Anchorable Guide Catheter
[0077] Referring to FIGS. 2-2b' there is provided an anchorable
guide catheter which is useable in conjunction with i) an imaging
catheter such as a commercially available IVUS catheter (e.g., 29
French Ultra-Cross available from Boston Scientific, 27 Orleans
Dr., Sunnyvale, Calif.) and ii) a transvascular passageway forming
catheter, one example of which is shown in FIGS. 3a-3d of this
application and other examples of which are described in U.S.
patent applications Ser. No. 08/730,327 and 08/730,496.
[0078] The anchorable guide catheter 50, comprises a pliable
tubular catheter body 52 having a proximal end PE and a distal end
DE. First and second lumens 54, 56 extend longitudinally through
the catheter body 52. An opening 58 is formed in one side of the
catheter body 52, so as to provide an opening into the first lumen
54. A pressure exertive member such as a balloon 59 or other
projectable apparatus such as a moveable foot, is mounted on the
catheter body 52 at a location laterally opposite the location of
the opening 58. An inflation fluid aperture 60 is formed in the
sidewall of the catheter body 52 between the balloon 58 and the
second lumen 56 such that balloon inflation fluid may pass into and
out of the balloon 59, through the second lumen 56.
[0079] A proximal connector assembly 62 is mounted on the proximal
end PE of the catheter body 52. Such proximal connector assembly 62
has a side arm port 64 in communication with the second lumen 56
such that balloon inflation fluid may be injected or withdrawn
through the side arm port 64 to cause alternate inflation and
deflation of the balloon 59. Also, the proximal connector assembly
62 has a proximal port 66 through which any elongate member of
suitable size and configuration, such as the imaging (IVUS)
catheter, a passageway forming catheter 40, or other catheters
equipped for introducing channel connectors, channel sizers, lumen
blockers, etc. as described in Applicant's earlier-filed U.S.
patent application Ser. Nos. 08/730,327 and 08/730,496, may be
advanced through the first lumen 54 of the catheter body 52. The
first lumen 54 of the catheter body 52 may be of a shape or
configuration which is analogous to one or both of the catheters
which are to be inserted through the first lumen 54 such that when
such IVUS catheter, passageway forming catheter 70 or other
elongate member 15 inserted into the first lumen 54, the outer
surface(s) thereof will engage the inner surface of the first lumen
54 such that the IVUS catheter, passageway forming catheter 70 or
other elongate member will be prevented from rotatably moving
relative to the body of the catheter 52, and the operator will
thereby maintain precise control over the rotational orientation of
these apparatus. In particular, as shown in FIGS. 2b-2c, the first
lumen 54 may have an inner lumenal surface 64 of a "D" shape.
[0080] Referring to FIGS. 3a-3d, a particular passageway forming
catheter 70 which is useable in conjunction with the anchorable
guide catheter 50 may comprise a pliable catheter body 72 having at
least a distal portion 74 having a generally D-shaped outer surface
76 which is of substantially the same size and configuration as the
D-shaped luminal surface 64 of the first lumen 54. A tissue
penetrating element 78 extends through the pliable catheter body 72
and is connected to a trigger 80 formed on the proximal hand piece
82 of the catheter device 70 such that, when the trigger 80 is
actuated, the tissue penetrating element 78 will pass out of a side
opening 80 formed in the D-shaped portion of the catheter body 72
such that the tissue penetrating element 78 will diverge laterally
from the longitudinal axis LA of the catheter body 72, in this
manner, the tissue penetrating element 78 may be utilized to form
an extravascular passageway which extends through the wall of the
blood vessel into which the catheter 70 is inserted, to another
blood vessel or other target location within the body.
[0081] Referring back to FIGS. 2a-2c', the anchorable guide
catheter 50 is initially inserted into the vasculature and advanced
to a position where the distal end DE of the balloon catheter body
52 and side opening 58 are located adjacent the location at which
it is desired to form an extravascular passageway. An imaging
catheter 80, such as an IVUS catheter, is inserted through the
proximal port 66, and is advanced through the first lumen 54 until
the imaging catheter 80 is in a position relative to the side
opening 58 of the catheter body 52 to provide an image of
anatomical structures located in alignment with such side opening
58. Thereafter, the guide catheter body 52 may be manually rotated
until the image received through the imaging catheter 58 indicates
that the opening 58 is directly aligned with the location at which
the extravascular passageway is to be formed. In this regard, the
catheter body 52 is of a torqueable construction, and may have the
same dual-layer braided construction as described hereabove with
respect to the torqueable sheath 10. In this manner, the anchorable
guide catheter 50 may be manually rotated by the operator to effect
precise rotational positioning of the opening 58 of the balloon
anchorable guide catheter within the vasculature or other luminal
anatomical structure within which the guide catheter 50 is
inserted.
[0082] After the opening 58 of the balloon anchorable guide
catheter 50 has been precisely rotationally positioned so that a
passageway forming catheter 70 subsequently inserted through the
guide catheter 50 will be appropriately aimed at the target
anatomical location, the balloon 59 of the guide catheter 50 will
be inflated (or the other pressure exertive member will be
actuated) to engage the surrounding luminal anatomical wall and to
hold the distal portion of the guide catheter 50 in substantially
fixed longitudinal and rotational position/orientation. In this
regard, the material in which the balloon 59 is formed may be
frictionally textured or coated with adhesive or otherwise modified
with a friction producing outer surface to enhance its friction
against the luminal wall. In this manner the balloon 59 will
soundly engage the surrounding luminal wall to hold the distal
portion of the guide catheter 50 in fixed position.
[0083] Thereafter, the imaging catheter 80 will be extracted from
the first lumen 54, and a passageway-forming catheter such as that
shown in FIGS. 3a-3d and described hereabove, will then be inserted
through the lumen 54. The passageway forming catheter 70 may be
advanced until the distal end DE of the passageway forming catheter
body 72 abuts against the distal end surface 82 of the first lumen
54 of the guide catheter 50. When so inserted, the D-shaped outer
surface 76 of the distal portion 74 of the passageway forming
catheter body 72 will be in abutment with the D-shaped luminal
surface 64 of the first lumen 54 of the guide catheter body 52, as
shown in FIG. 2c'. In instances where the proximal portion (i.e.,
that portion proximal to the distal portion 74) of the passageway
forming catheter body 72 is not of the same D-shaped configuration,
such proximal portion may simply reside within the D-shaped first
lumen 54 in the manner shown in FIG. 2b. Thus, it is not necessary
that the entire length of the passageway-forming catheter body 72
have the D-shaped outer surface 76, but only that a distal portion
72 thereof have the D-shaped outer surface 76 so as to frictionally
engage the D-shaped luminal surface 64 of the first lumen 54 in the
manner shown.
[0084] Because the anchoring balloon 59 has been inflated, the
guide catheter body 52 will be prevented from rotating within the
vasculature and will be held in a substantially fixed rotational
orientation such that the side opening 58 is in direct alignment
with the other blood vessel or target location to which the
extravascular passageway is to extend. Thus, after the
passageway-forming catheter 70 has been inserted into the first
lumen 54 in the above-described manner, the triggering member 80
may be actuated to cause the tissue penetrating element 78 to pass
out of the passageway forming catheter body 72, through the side
opening 58 of the guide catheter, through the wall of the blood
vessel in which the guide catheter 50 is located, and into another
blood vessel or other extravascular target location. In some
embodiments, the tissue penetrating element 78 may comprise a
tubular member having a guidewire lumen 81 extending longitudinally
therethrough. When such guidewire lumen 81 is present, a guidewire
79 may optionally be advanced through the tissue penetrating
element 78 and into the other blood vessel or extravascular target
location, after the tissue-penetrating element 78 has been advanced
thereinto. After such guidewire 79 has been advanced into the other
blood vessel or extravascular target location, the tissue
penetrating element 78 may be retracted into the body of the
passageway forming catheter 70, and the passageway forming catheter
70 and balloon anchorable guide catheter 50 may be extracted from
the body, leaving the guidewire 79 in place to guide other devices
or operative instruments through the newly created extravascular
passageway.
[0085] iii. Passageway-Forming Catheter Device Having Torqueable
Proximal Portion
[0086] FIGS. 4a-4e show another passageway-forming catheter device
100 of the present invention, which generally comprises an elongate
catheter body 102 with definable proximal 104, medial 106 and
distal 108 segments of varying flexibility and torque strength.
[0087] The proximal segment 104 and medial segment 106 of the
catheter body 102 incorporate reinforcement members, such as a
reinforcement member braid 110, which will impart structural
integrity to the proximal segment 104 and medial segment 106, and
will enhance the ability of the proximal segment 104 and medial
segment 106 to transmit torque from the proximal end of the
catheter body 102. In some embodiments, the distal segment 108 may
also incorporate such reinforcement members and/or braid 110. The
reinforcement members and braid may be similar to or the same as
that described in detail hereabove in reference to FIG. 1.
[0088] As shown in FIG. 4a, the proximal segment 104 may be of
greater diameter than the medial segment 106. In this manner, the
proximal segment 104 may comprise a cylindrical, dual lumen core
member 140a of a first diameter D.sub.1 about which the
reinforcement members or wire braid 110 are wrapped. An outer
jacket 142a is then formed about the reinforcement members or wire
braid 110, as shown in FIG. 4b.
[0089] The mid-portion 106 comprises a cylindrical core member 140b
of diameter D.sub.2, about which the reinforcement members or wire
braid 110 are wrapped. A cylindrical outer jacket 142b is also
formed about the mid-portion 106 of the catheter body 102, and is
continuous with the outer surface of the distal portion 108, as
shown in FIG. 4a.
[0090] It would be appreciated that the individual portions or
members which make up each segment of 104, 106, 108 of the catheter
body 102 may be formed of materials which have different physical
properties (e.g., hardness, flexural properties, etc.) so as to
bring about the desired regionalized variations in pliability and
torque strength the catheter body 102. For example, in a presently
preferred embodiment, the cylindrical core member 140a of the
proximal portion 104 is formed of a polymer material of a first
hardness (e.g., Pebax of 63E Shore Hardness) and the cylindrical
core member 140b of the mid-portion 106 is formed of a polymer
material having a different hardness (e.g., Pebax of 40D Shore
Hardness). The outer jacket 142 a of the proximal portion 104 is
formed of another polymeric material having yet a different
hardness (e.g., Pebax 70D Shore Hardness) and the outer jacket 142d
of the mid-portion 106 is formed of polymeric material having the
same or similar hardness of that of the mid-portion 106 (e.g.,
Pebax of 40D Shore Hardness) other polymeric materials which may be
used to form portions or members of the catheter body 102 include
nylon, polyurethane, polyester, polyvinyl chloride (PVC) etc.
[0091] The catheter body 102 has a bottom portion BP and an upper
portion UP. A curved or slanted frontal surface is formed on the
distal end of the upper portion UP.
[0092] A first lumen 130 extends longitudinally through the
catheter body from the proximal end to the distal end of the upper
portion of the catheter body, and terminates distally at the distal
outlet aperture 134.
[0093] A second lumen 132 also extends longitudinally through the
catheter body from the proximal end thereof to a closed end wall or
plug at the distal end of the lower portion LP of the catheter body
102. A proximal connector 136 is mounted on the proximal end of the
catheter body. A proximal connector 136 has a proximal end port 134
and a side arm port 138. The proximal end port 134 is in
communication with the first lumen 130 of the catheter body 102,
and the side arm port 138 is in communication with the second lumen
132 of the catheter body 102. A tissue-penetrating element 150
extends through the first lumen 130. This tissue penetrating
element 150 may be any suitable type of tissue penetrating element
member, device, or flow of energy, as previously described in U.S.
patent application Ser. No. 08/730,324, of which this application
is a continuation-in-part. In embodiments wherein the tissue
penetrating element 150 is an advanceable member or device, a
handpiece of the type shown in FIG. 3a-3b may be mounted on the
proximal end port 134 such that the trigger 80 is connected to the
tissue penetrating element 150 and is useable to alternately
advance and retract the tissue penetrating element 150, out of/into
the outlet aperture 134.
[0094] An imaging catheter, such as an intravascular ultrasound
(IVUS) catheter may be inserted through one of the ports 134, 138
of the proximal connector 136 connected to the second lumen 132. In
this manner the imaging catheter (IVUS) may be advanced through the
second lumen 132 such that a distal portion of the imaging catheter
extends into or out of and beyond the distal extent of the second
lumen 132, thereby placing the imaging transducer or image
receiving apparatus at a vantage point which is distal to the
outlet aperture 134. Such imaging catheter may then be utilized to
image anatomical structures which are situated adjacent to in the
vicinity of the outlet aperture 134, and to view the passage of the
tissue-penetrating element 150 out of the outlet aperture 134 and
through/into the adjacent anatomical structure.
[0095] iv. A Deflectable Catheter System for Forming Extraluminal
Passageways
[0096] FIGS. 7-7b show another type of catheter system which may be
utilized to form interstitial passageways between a luminal
anatomical structure (e.g., a blood vessel) within which the
catheter is positioned and another target anatomical location
(e.g., another blood vessel, chamber of the heart, organ, tumor,
etc.).
[0097] As shown in FIG. 7, the system 1000 comprises a deflectable
tipped catheter 110 which is useable in combination with an imaging
catheter 112 (e.g., an IVUS catheter) and a tissue penetrating
element 114 (e.g., a sharp-tipped elongate member, or a flow of
tissue-penetrating energy).
[0098] The deflectable tip catheter 110 comprises an elongate
pliable catheter body 1016 having a deflectable distal end DE and a
proximal end PE which is connected to a handpiece 1018.
[0099] A presently preferred construction of the handpiece 1118 is
shown in FIG. 7a, and a presently preferred construction of the
distal end DE of the catheter body 1016 is shown in FIG. 7b.
[0100] A working lumen 1020 extends longitudinally through the
catheter body 1016 and through an opening 1022 in the distal end DE
of the catheter body 1016. A secondary lumen 1026 extends
longitudinally through the catheter body 1016, at an off center
location along one side of the catheter body. Such secondary lumen
1026 terminates within the catheter body near the distal end
thereof, and is thus a blind lumen. A pull wire 1024 extends
longitudinally through the secondary lumen 1026 and the distal end
1028 of the pull wire 1024 is anchored or attached to the catheter
body at a location within the catheter body, near the distal end
thereof. The pull wire 1024 is axially moveable within the
secondary lumen 1026 such that, when the pull wire 1024 is
retracted in the proximal direction, it will cause the distal end
DE of the catheter body 1016 to deflect in lateral direction,
toward the side on which the secondary lumen 1026 is formed, as
shown in FIG. 7b.
[0101] The handpiece 1018 comprises a rear body portion 1030 and a
forward body portion 1032 a knob 1034 is formed on the forward body
portion 1032. The proximal end of the forward body portion 1032 is
received within an inner bore 1036 of the rear body portion 1030
and is slidably retractable and advanceable within such bore 1036.
A tubular member 1038 is positioned axially within the bore 136 of
the rear body portion 1030 and extends through a portion of the
forward body portion 132 as shown. This tube member 1038 is
attached and anchored within the handpiece 1018 by way of a nut
1039. The catheter body 1016 extends through the tubular member
1038 and the proximal end PE of the catheter body 1016 is anchored
within the rear body portion 1030, as shown. A slot 1040 is formed
in the side of the tube member 1038. The pull wire 1014 extends
through a small hole formed in the side of the catheter body 1016
within the forward body portion 1032 and through the slot 1040. The
proximal end of the pull wire 1024 is attached to a set screw 1042
mounted in the side of the forward body portion 1032. An 0-ring
1046 is mounted within an annular groove formed in the proximal
portion of the forward body portion 1032 such that the 0ring will
ride against the inner surface of the bore 1036 of the rear body
portion 130 as the forward body portion 1032 is advanced and
retracted therewithin.
[0102] In operation, when it is desired to cause the distal end DE
of the catheter body 1016 to deflect laterally, the operator will
grasp the knob 1034 of the forward body portion 1032 and will
proximally retract the forward body portion 1032 into the bore 1036
of the rear body portion 1030, while the catheter body 1016 remains
axially stationary due to its affixation to the proximal body
portion 1030. In this manner, the pull wire 1024 will be proximally
retracted within the secondary lumen 1026 and will cause the distal
end DE of the catheter body 1016 to deflect in the desired lateral
direction, as shown. Such deflection of the distal end DE of the
catheter body 1016 may be utilized to cause the distal end outlet
aperture 1022 to be specifically directed or aimed at the luminal
wall of a luminal anatomical structure within which the catheter
body 1016 is inserted.
[0103] A first frusto conical bore 1050 is formed within an insert
member 1052 located in the rear body portion 1030, and within which
the proximal end PE of the catheter body 116 is extended. This
frusto conical bore 1050 leads directly into the proximal end of
the working lumen 1020 of the catheter body 1016 and will
facilitate distally directed advancement of a guidewire, imaging
catheter 1012, tissue penetrating element 1014, or other elongate
apparatus through the main lumen 1020 of the catheter body
1016.
[0104] Another insert member 1054 having an opposite redirected
frusto conical bore 1056 is also mounted within the bore 1036 of
the rear body portion 1030, proximal to the first insert member
1052. This oppositely directed frusto conical bore 1056 will serve
to guide and center the proximal end of a guidewire or similar
elongate apparatus over which the catheter body 116 may be advanced
such that it passes out of the proximal end PE of the catheter body
116.
[0105] Optionally, a hemostasis valve and/or gripping apparatus
1060 may be mounted on the proximal end of the rear body portion
130, immediately adjacent the proximal end opening 1062 of the bore
136 through which the guidewire(s), imaging catheter 1012, tissue
penetrating element 1014 or other elongate apparatus may be
passed.
[0106] In a preferred mode of operation, the catheter body 1016 is
initially inserted into a luminal anatomical structure such that
the distal end DE of the catheter body 1016 is located generally
adjacent a site at which an interstitial passageway is to be formed
through the wall of the luminal anatomical structure within which
the catheter body 1016 is positioned. The imaging catheter 1012
(e.g., an IVUS catheter) is advanced through the proximal opening
1062, through the frusto conical bore 1050, and through the working
lumen 1020 of the catheter body 1016 until the transducer or
image-receiving element of the imaging catheter 1012 is
appropriately positioned to image the side wall of the luminal
anatomical structure within which the catheter body 1016 is
inserted and/or the target anatomical location to which the
interstitial passageway is desired to extend. In many instanced,
this will require that a distal portion of the imaging catheter
1012 protrudes slightly out of and beyond the distal end opening
1022 of the working lumen 1020. With the image catheter 1012 in its
operative position, it may be utilized to precisely locate the
distal end DE of the catheter body 1016 in the desired longitudinal
location and rotational orientation which will cause the distal end
opening 1022 to be in alignment with the specific site on the wall
of the luminal anatomical structure through which the passageway is
to be formed. In this manner, one or more imageable markers or
other aiming/positioning systems as described in this patent
application or in applicant's related patent applications may be
incorporated into the system 1000 to facilitate precise aiming and
positioning of the distal end DE of the catheter body 1016.
[0107] After the distal end DE of the catheter body 1016 has been
longitudinally and rotationally positioned/oriented, the imaging
catheter 1012 will be extracted and removed, and the
tissue-penetrating element 1014 will then be advanced through the
proximal opening 1062, through the frusto conical bore 1050, and
through the working lumen 1020 until the tissue-penetrating element
is near the distal end opening 1022 but still contained within the
working lumen 1020. Thereafter, the operator will grasp the knob
1034 of the handpiece 1018 and will retract the forward body
portion 1032 of the handpiece rearwardly, into the rear body
portion 1030. This will cause the pull wire 1024 to retract and
will cause the distal end DE of the catheter to become laterally
deflected such that the distal end opening 1022 is positioned in
direct alignment with the site on the wall of the luminal
anatomical structure through which the passageway is to be formed.
Thereafter, the tissue-penetrating element 1014 will be further
advanced out of the distal end opening 1022 of the catheter body
1016, through the wall of the luminal anatomical structure, and
through any intervening tissue, until the tissue-penetrating
element 1012 emerges into the intended target anatomical
location.
[0108] Thereafter, the tissue-penetrating element 1014 may be
retracted through the working lumen 1020 and removed.
[0109] Thereafter, one or more secondary apparatus (e.g., channel
connector delivery catheters, channel enlarging/modifying
catheters, blocker catheters, etc.), may be advanced through the
working lumen 1020 of the catheter to perform any desired
modifications of the interstitial passageway or delivery of
ancillary devices to facilitate flow of blood or biological fluids
through the passageway, as desired.
[0110] Thereafter, when the procedure has been completed, the
operator may again grasp the knob 1034 of the forward body portion
1032 and may distally advance the forward body portion to its
original position, thereby allowing the distal end DE of the
catheter body 1016 to return to its substantially straight,
non-deflected configuration.
[0111] Those skilled in the art will appreciate that various
modifications or changes may be made to the above-described system
1000 without departing from the intended spirit and scope of the
invention. For example, although the preferred embodiment has been
shown with a single working lumen 1020 extending through the
deflectable catheter 1010, a plurality of such lumens may be formed
to allow multiple components (e.g., the imaging catheter 112 and
the tissue penetrating element 1014 and/or a guidewire (not shown))
to extend through the catheter body 1016 simultaneously. However,
in many applications it will be desirably to minimize the diameter
of the catheter body 1016 and to maximize its pliability or
flexibility, thereby rendering it desirable to utilize a single
lumen 1020 in such applications.
[0112] Optionally, a side port 1057 may be formed in the rear body
portion 1030 to permit infusion/withdrawal of fluid through the
working lumen 1020 of the catheter 1000.
[0113] V. Markers and Related Apparatus for Positioning/Aiming The
Passageway Forming Catheters
[0114] FIGS. 4d-6c show various markers and other apparatus which
may be incorporated into any of the passageway forming catheters
described in this patent application or any other suitable
catheter, to provide a means for visually determining (e.g., by
intracorporeal imaging such as intravascular ultrasound, or by
extracorporeal imaging such as fluoroscopy) the precise positioning
and rotational orientation of the distal portion of the catheter
and/or for precisely aiming the tissue-penetrating element so that
it will create the desired interstitial passageway as it is passed
out of the passageway-forming catheter.
[0115] In particular, FIGS. 4d-4e show markers which are
particularly suitable for use on passageway-forming catheters which
have a stepped or slanted distal end configuration, such as that of
the torqueable catheters shown in FIG. 4a. The remaining showings
of FIGS. 4g-6c show markers and guidance/aiming apparatus which are
useable with passageway-forming catheters which have various distal
end configuration.
[0116] Referring to FIG. 4d, there is shown a distal portion of a
passageway-forming catheter 100 hereupon a generally U-shaped
marker 180 is mounted on the upper surface of the lower catheter
body, distal to the tissue-penetrating outlet opening 134. The
longitudinal midline of the marker 180 is in alignment with the
path which will be followed by the tissue penetrating element 150
as it is advanced out of the opening 134 in the catheter 100. In
this manner, an imaging apparatus such as an IVUS catheter
positioned within the lower catheter body portion at a vantage
point distal to the distal end of the tissue-penetrating element
outlet opening 134, may be utilized to ensure that the marker 180
is in direct alignment with the target tissue prior to advancement
of the tissue penetrating element 150 out of the opening 134.
[0117] FIG. 4e shows a passageway forming catheter 100 having a
marker strip 182 mounted on the upper portion of the lower catheter
body, distal to the location of the tissue-penetrating element
outlet opening 134. This marker strip 182 creates an image artifact
which extends out radially to allow *point* in a specific direction
which corresponds to the path of the tissue penetrating element.
The longitudinal midline of this marker strip 182 is in alignment
with the path which will be followed by the tissue-penetrating
element 150 as it passes out of the opening 134. In this manner, an
imaging apparatus such as an IVUS catheter positioned within the
lower catheter body portion at a vantage point distal to the distal
end of the tissue-penetrating element outlet opening 134, may be
utilized to ensure that the marker strip 184 is in direct alignment
with the target tissue, prior to advancement of the tissue
penetrating element 150 out of the opening 134.
[0118] FIG. 4f shows a wire marker 186 mounted on the distal
portion of a passageway-forming catheter 100 which has an optional
imaging window 101 formed in the lower catheter body, distal to the
tissue-penetrating element outlet opening 134. The details of this
imaging window were previously described in applicant's
earlier-filed U.S. patent application Ser. No. 08/730,496. The wire
marker 186 comprises a single, elongate wire which is attached at
its opposite ends, to the proximal and distal boarders of the
window 101. The elongate wire marker 186 is preferably in the
center of the window 101 and in alignment with the path which will
be followed by the tissue penetrating element 150 as it is advanced
out of the opening 134 in the catheter 100. In this manner, an
imaging apparatus such as an IVUS catheter positioned within the
lower catheter body portion so as to obtain an image through the
imaging window 101, may be utilized to ensure that the marker wire
186 is in direct alignment with the target tissue prior to
advancement of the tissue penetrating element 150 out of the
opening 134.
[0119] FIG. 4g shows another passageway-forming catheter 100' which
has an imaging lumen 300 through which an imaging catheter may be
advanced, and a working lumen 302 through which a
tissue-penetrating element 150 may pass, such working lumen 302
terminating distally in an outlet opening 134 formed in the side of
the catheter 100' at a spaced distance proximal to the distal end
of the imaging lumen 300, as shown. A pliable distal tip member 189
is mounted on the distal end of the catheter 100', and the imaging
lumen 300 extends through such tip member 189 and terminates in a
distal opening formed therein. Additionally, a hollow passageway
191 extends longitudinally through such tip member 189 in direct
alignment with the main portion of the working lumen 302. An
imagable marking wire member 188, preferably formed of a
combination of platinum and stainless steel, extends through the
hollow passageway 191 in the tip member 189, and is surrounded
laterally by a gap or space 193 within such passageway 191, as
shown. The proximal end of this wire member 188 is embedded in a
mass of imagable material 190 located within the body of the
catheter 100'. Such mass of imagable material 190 is preferably a
mixture of tungsten and a plastic (e.g., Pebax) or platinum. The
distal end of the wire member 188 protrudes out of and beyond the
distal end of the catheter body, as shown.
[0120] FIGS. 4h-4h' show another passageway-forming catheter 100''
comprising an elongate pliable catheter body having an imaging
lumen 300 and a working lumen 302. An imaging apparatus, such as
IVUS catheter, is advanceable through the imaging lumen 300. A
tissue penetrating element (not shown) is passable through the
working lumen 302 and out of the outlet aperture 134. A marker wire
lumen 314 extends through a distal portion of the catheter 100''
between a proximal opening 316 formed in the upper wall of the
imaging lumen 300, and a distal outlet aperture 318 formed in the
distal end of the catheter 100'', above the distal end outlet 320
of the imaging lumen 300. A marker wire 310 is disposed within the
imaging wire lumen 314. A proximal bulb 322 is formed on the
proximal end of the marker wire 310, and an optional distal bulb
324 may be formed on the distal end thereof. Initially, the marker
wire 310 is fully retracted into the marker wire lumen 314 such
that its distal tip and any distal bulb 324 is wholly contained
within the body of the catheter 100'', and with the proximal bulb
322 protruding slightly into the imaging lumen 300. The marker wire
may be spring loaded or otherwise biased to this proximally
retracted position. Thereafter, when an IVUS catheter is advanced
through the imaging lumen 300, the distal end of the advancing IVUS
catheter will drive the proximal bulb 322 of the marker wire 310
into a proximal cavity 326 formed at the proximal end of the marker
wire lumen 314, thereby advancing the marker wire 310 such that a
portion of the marker wire and its distal bulb 322 extends out of
the distal end outlet aperture 318 and protrudes beyond the distal
end of the catheter 100'', as shown in FIG. 4h. The distal bulb 322
and a longitudinal axis of the marker wire 310 are in direct with
the path which will be followed by a tissue-penetrating element
(not shown) as it passes out of the outlet aperture 134. Thus, when
the distal bulb 322 of the distally advanced marker wire 310 is in
direct alignment with the target tissue on the image received by
the IVUS catheter, such will ensure that when the tissue
penetrating element is advanced out the outlet aperture 134, it
will be properly aimed and will advance into the target tissue, as
desired.
[0121] FIGS. 4i and 4i' show another passageway-forming catheter
100''' having an imaging lumen which terminates in a distal outlet
aperture 320 and a working lumen which terminates in a side outlet
aperture 134. An imaging catheter, such as an IVUS is advanceable
through the imaging lumen, and a tissue-penetrating element (not
shown) is advanceable out of the side outlet aperture 134.
[0122] In the particular embodiment shown in FIG. 4i, an arcuate
wire marker 330 is mounted on the distal end of the catheter
100''', in a generally horizontal plane, above the distal out end
outlet 320 of the imaging lumen 300. This arcuate wire marker 330
may be imaged by the transducer of an imaging catheter which
protrudes out of the distal end outlet 320, and a specific, region
of the artifact or image produced by the arcuate wire marker 330
may be fused, aimed or aligned with the target tissue, taking into
account the distance between the catheter 100 and the target
tissue, thereby ensuring that when the tissue penetrating element
(not shown) is advanced out of aperture 134 it will extend into the
intended target anatomical location or tissue.
[0123] In the alternative embodiment shown in FIG. 4i', there is
provided a 3-legged wire marker 332 mounted on the distal end of
the catheter 100'''. Such 3-legged wire marker 332 comprises bottom
legs 334 formed of single wire strands and an upper leg 336 formed
of a single wire strand additionally having an outer wire coil
formed therearound. The single wire strand and the outer wire coil
may be formed of different materials. The upper leg 336 is in
direct longitudinal alignment with the half which will be followed
by the tissue penetrating element as it passes out of the side
outlet aperture 134 of the catheter 100'''. In this manner, when an
imaging catheter such as an IVUS is advanced out of the distal end
opening 320 of the imaging lumen, it may be utilized to directly
align the upper leg 336 of the three-legged wire marker 322 with
the intended target tissue, thereby insuring that when the tissue
penetrating element is passed out of the side outlet aperture 134,
it will form the desired passageway into the target tissue.
[0124] FIGS. 4j-4j' show a passageway forming catheter 100'''
having the same configuration as that of FIGS. 4i-4i', but wherein
a deflectable wire marker 340 is mounted on the end of the catheter
100''', as shown. Such deflectable wire marker 340 preferably
comprises a singe wire strand having an additional wire coil formed
therearound. This deflectable wire marker 340 has a top end 342
which is attached to the body of the catheter 100''' at a site
which is in direct longitudinal alignment with the side outlet
aperture 134. When the deflectable wire marker 340 is in its
non-deflected position (FIG. 4j) its bottom end 344 will protrude
downwardly over the distal end outlet 320 of the imaging lumen 300.
Thus, when an imaging catheter such as an IVUS catheter is advanced
through the imaging lumen 300 and out of the distal end outlet
aperture 320 it will abut against the bottom portion of the
deflectable wire marker 340, thereby causing the deflectable wire
marker 340 to assume a deflected position as shown in FIGS. 4j'.
When the deflectable wire marker 340 is in such deflected position,
the longitudinal axis of the deflectable wire marker 340 will be in
direct alignment with the path which will be followed by the tissue
penetrating element (not shown) as it is passed out of the side
outlet aperture 134. In this manner, the imaging catheter (IVUS)
may be utilized to directly align the longitudinal axis of the
deflectable wire marker 340 with the target tissue, thereby
insuring that when the tissue penetrating element is passed out of
the side outlet aperture 134 it will form the desired interstitial
passageway into the target tissue.
[0125] FIG. 4k shows the same tissue-penetrating catheter 100'''
wherein a secondary guidewire lumen 348 extends longitudinally
through the body of the catheter 100''', from a proximal aperture
350 formed in the distal curved surface of the working lumen 302 to
a distal guidewire outlet aperture 352 formed in the distal end of
the catheter body, as shown. In this embodiment, the tissue
penetrating element 150' comprises an elongate member having a
sharpened distal end and a hollow guidewire lumen extending
longitudinally therethrough. A guidewire 356 is advancable through
the guidewire lumen of the tissue penetrating element 150'. When
the tissue penetrating element 150 is retracted into the working
lumen 302 as shown in FIG. 4k, the guidewire 356 may be advanced
out of the distal end of the tissue penetrating element 150,
through the secondary guidewire lumen 348, wherein it will act as a
marker which may be imaged by a imaging apparatus (e.g., an IVUS
catheter) passed through the imaging lumen 300. The longitudinal
axis of the guidewire 356, when positioned within the secondary
guidewire lumen 348, will be in direct alignment with the path
which will be followed by the tissue penetrating element 150 as it
is advanced out of the side outlet aperture 134.
[0126] The showing of FIG. 4k also incorporates a separate
image-enhancing means whereby energy (e.g., ultrasonic vibration)
may be imparted to the tissue penetrating element 150' as it is
advanced out of the side outlet aperture 134 to render the distal
portion of the tissue penetrating element 150' more easily visible
by the imaging apparatus (e.g., IVUS catheter) positioned in the
imaging engage the wall of the imaging lumen 300 to prevent the
phased array imaging catheter 374 from rotating within the imaging
lumen 300. An electronic marker is formed within the circuitry of
the phased array imaging catheter 374 so as to mark a desired
location L which is in direct alignment with the outlet aperture
134 of the catheter 100''' when the phased array imaging catheter
374 is non-rotatably inserted into the imaging lumen 300. In this
manner, the electronically marked location L may be placed in
direct alignment with the target tissue viewed on the image
received through the phased array imaging catheter 374, thereby
insuring that the outlet aperture 134 is also in alignment with the
target tissue. It should be appreciated, that as an alternative to
internally or electronically marking the desired location L on the
phased array transducer 376, various imagable markers may be formed
on the body of the catheter 100''' to mark the rotation of the
outlet aperture 134, examples of such imagable markers being
described hereabove and shown in FIG. 4d-4k.
[0127] One example of an electrical system which may be utilized to
electronically mark a desired location L on the image received from
the phased array transducer 376 is shown, in schematic fashion, in
FIG. 4I'. With reference to FIGS. 4I and 4I', the phased array
transducer 376 of the phased array imaging catheter 374 has a
plurality of individual crystals 900 formed at spaced-apart
locations on the transducer 376. Wires 902 extend from each of the
individual crystals 900 of the phased array transducer 376, through
the body of the phased array imaging catheter 374 and out of the
proximal end thereof. One of these individual wires 902a is
separated from remaining wires 902b, and the remaining wires 902b
extend directly into a monitoring console 904 which produces the
viewable image from the phased array transducer 376. The selected
wire 902a is connected to a switch 906. When the switch 906 is in
its open position, the signal received from the selected wire 902a
will be shunted through a bypass circuit 908 which rejoins the
remaining wires 902b prior to entry into the monitoring console
904. In this manner, when the switch 906 is open, the signal
received from the selected wire 902a will bypass the signal
modifying apparatus 903 and will rejoin the signals received from
the remaining wires 902b to provide an image on the image
monitoring console 904 which is unchanged and unmarked. However,
when the switch 906 is closed, the signal received from the
selected wire 902a will pass through a signal modifying apparatus
903. This signal modifying apparatus 903 may simply be an open
switch which terminate the signal, thereby providing a void in
place of the image which would be displayed from the individual
crystal 900 from which the selected wire 902a extends.
Alternatively, such signal modifying apparatus 903 may be a
saturation apparatus which will produce white noise, or a color
imparting apparatus which will tint or color the image received
from the selected wire 902a. In either case, the image which
subsequently appears on the image monitoring console 904 from the
selected crystal 900 from which the selected wire 902a extends will
be visually discernable by the operator and will provide a marking
of the desired location L on the phased array imaging transducer
976.
[0128] FIGS. 4m and 4m' the presently preferred embodiment
comprising a catheter 100'''' wherein a segment of the catheter
body is cut away, with a plurality (e.g., (three (3)) struts 402,
404, 406 formed a connection between a proximal portion 408 of the
catheter 100'''' and a distal portion 410 thereof, so as to form an
imaging cage wherein the imaging catheter (e.g., IVUS) may be
positioned. The top strut member 404 is of elongate configuration,
and it longitudinal axis is directly aligned with the side outlet
screen which directly correlates to the path which will be followed
by the tissue-penetrating element, such artifact (e.g., ray or
streak) being useful to enable the operator to determine the
precise path which will be followed by the tissue penetrating
element. In other applications, the marker may be formed of
material which is reflective of the energy form such that a bright
spot or exaggerated area will appear on the image screen when such
marker is surrounded by tissue or other matter which is less then
totally reflective of the energy form. Thus, in addition to the
above-described methods for modifying the markers by applying
energy (e.g., ultrasound) to the body of the marker, the exact form
of the image or artifact produced by the marker may also be altered
or optimized by forming the marker of a particular material of
varied acoustic impedance, ranging from air or fluid filled
cavities, to solid materials, to produce a range of marker effects
on the image produced.
[0129] FIG. 5 shows an alternative positioning-aiming system which
is useable to facilitate precise positioning and aiming of the
passageway forming catheter 100a. In this system, a signal emitting
apparatus 500 is positioned in the target area (e.g., within a
second blood vessel BV.sub.2) and a signal receiving apparatus 502
is mounted within the passageway-forming catheter 100a located
within in a first blood vessel BV.sub.1. The signal emitting
apparatus 500 comprises a signal emitting wire 504 having a tubular
shield 506 surrounding the shaft of the wire such that only a
distal portion 508 of the wire 504 extends out of the distal end of
the shielding tube 506. The shielding tube 506 may comprise any
suitable electromagnetic shielding material, and is preferably
formed of a pliable plastic tube having an aluminum braid formed
therein. Those skilled in the art will appreciate that the signal
emitting wire 504 may be attached to an extracorporeally located
signal generating apparatus capable of passing an electromagnetic
signal through the wire 504. Such electromagnetic signal may be a
20 Khz signal.
[0130] The signal receiving apparatus 502 is preferably formed
within the wall of the passageway forming catheter 100a laterally
outboard of the working lumen 302 through which the tissue
penetrating element is passed, and in direct alignment with the
tissue penetrating element outlet aperture 134 formed in the side
of the catheter 100a. Optionally, the catheter 100a may also
include an imaging lumen 300 through which and imaging catheter
(e.g., an IVUS catheter) may be passed. However, those skilled in
the art will appreciate that in many applications the signal
emitting apparatus 500 and signal receiving apparatus 502 will be
operable to control the precise positioning and rotational
orientation of the catheter 100a, and such imaging lumen 300 may be
unnecessary.
[0131] The signal receiving apparatus 502 formed in the
passageway-forming catheter 100a comprises a signal receiving wire
510 having a tubular shielding apparatus 512 formed therearound.
The tubular shielding apparatus 512 surrounds the shaft of the
receiving wire 510 and a short distal portion 514 of the receiving
wire 510 extends out of and beyond the distal end of the tubular
shield 512. The tubular shield 512 may be formed in the same manner
as the above-described tubular shield 506 of signal emitting
apparatus 500. The exposed distal portion 514 of the signal
receiving wire 510 is located immediately adjacent, and in
longitudinal alignment with the side outlet aperture 134. In this
manner, an electro magnetic signal may be emitted through the
signal emitting apparatus 500 after it has been positioned within
the second blood vessel BV.sub.2 or other target tissue. The
longitudinal positioning and rotational orientation of the
passageway-forming catheter 100a inserted within the first blood
vessel BV.sub.1 may then be adjusted until the signal received by
the signal receiving apparatus 502 of the catheter 100a is at its
peak intensity, thereby indicating that the exposed distal portion
514 of the receiving wire 510 has been positioned at its closest
possible point to the exposed distal portion 508 of the signal
emitting wire 504. This will ensure that the passageway forming
catheter 100a is longitudinally positioned at the closest
straight-lined point from the signal emitting apparatus 500 located
within the second blood vessel BV.sub.2 or other target tissue, and
that the catheter 100a has been rotated to a rotational orientation
wherein the outlet aperture 134 is directly aimed at the signal
emitting apparatus 500 located within the second blood vessel
BV.sub.2 or other target tissue. It will be further appreciated by
those skilled in the art that various types of energy-emitting
signals may be utilized into, such that the signal emitting
apparatus 500 located within the second blood vessel BV.sub.2 or
target tissue is an "active" element and the signal receiving
apparatus 502 associated with the passageway forming catheter 100a
is a "passive" or receiving element. The types of signals which may
be utilized include, but are not necessarily limited to,
electromagnetic signals (as specifically described hereabove),
sonic signals (e.g., doppler), ultrasonic signals, high intensity
light, laser, radiofrequency, etc.
[0132] FIG. 5a shows another positioning/aiming system which is
wholly incorporated into the passageway-forming catheter 100b. A
signal emitting or "active" component 520, such as a piezoelectric
crystal is mounted upon or formed within the catheter 100b so to
emit a signal or flow of energy which will strike, enter or be
reflected from the target tissue T. A passive or receiving
apparatus, such as another piezoelectric crystal may be mounted at
a second location within or upon the catheter 100d so as to receive
a reflected signal or returning signal from the target tissue T.
The position of the passive or receiving apparatus 522 relative to
the active or emitting apparatus 520 is known, and may be utilized
to precisely determine the longitudinal position and rotation
orientation of the catheter 100b. In this manner, this
positioning/aiming system may be utilized to effect precise
longitudinal positioning and rotational orientation of the catheter
such that when the tissue penetrating element is passed out of the
outlet aperture 134, it will extend into the target tissue T, as
desired. Those skilled in the art will appreciate that, as an
alternative to the passive receiving apparatus 522, or in addition
thereto, an optional imaging lumen 300 may extend through the body
of the catheter 100b such that an imaging catheter (e.g., IVUS
catheter or receiving catheter carrying the passive receiving
apparatus 522 may be passed through such lumen 300 and utilized to
alternatively or additionally facilitate the positioning and
rotational orientation of the catheter 100b.
[0133] FIG. 5b shows yet another alternative positioning/aiming
system wherein a signal emitting crystal 530 is positioned on or
within the catheter 100c so as to emit a signal (e.g., ultrasound
or sound waves) in a direction which is specifically aligned with
the path which will be followed by the tissue penetrating element
as it passes out of the side outlet aperture 134 an imaging
catheter. An imaging catheter (e.g., an IVUS catheter) positioned
within the imaging lumen 300 is utilized to receive the signal from
the crystal 530 after it has reflected from the target tissue T,
thereby discerning the specific point of impingement X on the
target tissue T where it is struck by the energy being emitted by
the signal emitting crystal 530. In this manner, the imaging
catheter positioned within the imaging lumen 300 may be utilized,
to precisely position and aim the outlet aperture 134 of the
passageway-forming catheter at the energy impingement point X on
the target tissue T, thereby insuring that, when the tissue
penetrating element is advanced out of the outlet aperture 134, it
will extend into the target tissue T at a desired site.
[0134] Further referring to FIG. 5b, the signal emitting crystal
530 may be alternatively utilized as a signal receiving crystal,
such that it will receive reflected ultrasound from the IVUS, as
indicated by the dotted arrows on FIG. 5b. Since the signal
receiving crystal 530 is specifically positioned and oriented in
relation to the outlet 134 and/or path of the tissue penetrating
element 150, such receipt of the IVUS ultrasound by the signal
receiving crystal 530 will enable the operator to precisely
position and rotationally orient the catheter such that the tissue
penetrating element 150 will pass directly into the target tissue
T, in parallel to the path of reflected ultrasound received by the
signal receiving crystal 530.
[0135] FIG. 5c shows yet another positioning/aiming system wherein
the passageway-forming catheter 100d has a working lumen 302 which
terminates in a side outlet aperture 134 and through which a
tissue-penetrating element 500 in the nature of an elongate member
540 having a sharpened distal end may be advanced through such
working lumen 302 and out of the side outlet aperture 134 of the
catheter 100d. The elongate member 540 in this embodiment is
equipped with a sensor apparatus 548 positioned at or near the
sharpened distal end of the elongate member 540. A connector wire
550 may extend longitudinally through the elongate member 540 to
permit the sensor 548 to send a signal through the shaft of the
member 540 to an extracorporeal location at which such signal may
be processed and/or monitored. The sensor 548 may be any suitable
type of sensor which will sense the presence and/or location of the
intended target tissue T. Parameters or variables which may be
sensed by the sensor 548 include temperature, pulse, flow, or other
characteristics of the target tissue T, capable of being
mechanically, electronically or optically sensed. Additionally or
alternatively, an energy emitting or "active" apparatus, such as
the energy emitting apparatus 500 described hereabove with
reference to FIG. 5, may be positioned within the target tissue T
and the sensor 548 formed on the tissue penetrating member 540 may
be adapted to receive and sense energy emitted by the active energy
emitting member located within the target tissue T. In this manner,
the tissue penetrating member 540 serves its own sensing function
and enables the operator to control the longitudinal and rotational
position of the catheter 100d prior to or during the advancement of
the tissue penetrating member 540 out of the outlet aperture 134
and into the target tissue T. It will be appreciated by those
skilled in the art, when a tissue penetrating member 540 having an
onboard sensor 548 of the type described herein is utilized, such
will eliminate the need for any other extracorporeal or
intracorporeal imaging or sensing apparatus for aiding in
positioning or rotational orientation of the catheter 100b.
Alternatively, the catheter 100b may also be provided with other
onboard aiming/positioning apparatus or an imaging lumen 300 as
described in reference to various other embodiments shown in FIGS.
4-5.
[0136] FIG. 5d shows another aiming/positioning system which is
similar to that shown in FIG. 5b, but wherein the emitting member
530 (e.g., an ultrasound emitting piezoelectric crystal) is aimed
downwardly at the transducer or receiving port of the imaging
catheter (e.g., IVUS catheter), and the emitting member 530 is
specifically positioned relative to the outlet opening 134 so as to
provide an imageable marking at the outlet opening 134. In this
manner, the imaging catheter (IVUS catheter) may be used to
specifically site and identify the location of the outlet aperture
134, thereby facilitating longitudinal positioning and rotational
aiming of the catheter prior to deployment of the tissue
penetrating member 150.
[0137] FIG. 5e shows one embodiment of a system 790 which may be
utilized to facilitate optimization or peaking of the signal
received from a sensor or receiving component which is utilized to
position and aim the catheter, such as those described hereabove
and identified by reference numerals 502, 522, 530 and 548. In this
system 790, the wire 510, 521, 531, 550 through which a signal is
received from the receiving component 502, 522, 530, 548 is
connected to a switch 818. When the switch 818 is open, the signal
received will not enter the system 790. However, when the switch
818 is closed, the signal received from the receiving or sensing
component 502, 522, 530, 548 will enter a signal conditioning and
filtering component 880 wherein the signal will undergo
conditioning and filtering. Thereafter this signal will pass
through a rectifier 810 wherein the signal will be rectified, and
through a leaky integrator 812 of the type well known in the art.
Such leaky integrator 812 may comprise a capacitor and a resistor
in parallel. The integrated signal from the leaky integrator 812
may then pass into an analog to digital convertor 814, if desired,
whereby it will be converted to a digital signal, and such digital
signal will then be fed to a display 816 of a type suitable for
indicating the relative intensity of the signal received. Such
display may be an LED or multiple light display, whereby a column
or array of lights are provided and the intensity of the signal
received is indicated by the height of the column or the number of
lights in the array which are lit at any given time.
[0138] In this manner, the system 790 shown in FIG. 5d may be
utilized to enable the operator to longitudinally and rotationally
move the catheter until the signal received from the receiving
component or sensor 502, 522, 530, 548 has been peaked or
optimized, thereby indicating that the catheter is properly
positioned such that the tissue penetrating element will extend
from the outlet 130 into the target anatomical location T.
[0139] FIGS. 6-6c show other catheter marking schemes which may be
used in conjunction with an extracorporeal imaging apparatus 118,
such as a fluoroscope, positioned adjacent a mammalian body MB. In
the showing of FIG. 6, a catheter 100 has been advanced into the
blood vessel BV.sub.1, and such catheter is marked with one of the
marking schemes of this embodiment of the present invention. FIGS.
6a-6c show the manner in which the marking scheme of the catheter
100 will appear on the fluoroscopy screen 120 as the catheter is
rotated within the blood vessel BV.sub.1.
[0140] Referring to FIG. 6a, there is provided a marking scheme
which comprises a first radio-opaque linear marking 122 on one side
of the catheter body, and a second radioopaque linear marking 122b.
The second linear marking 122b is located directly and 180.degree.
opposite the first linear marking 122a, but slightly more distal to
the first marking 122a. An additional rotation indicating indicia
200, comprising the letter "R" formed of radio-opaque or other
imagable material, is formed to the right of the first linear
marking 122a. As shown in FIG. 6a, when the catheter is in its
desired rotational orientation, the first and second linear
markings 122a and 122b will appear next to and in linear alignment
with one another on the fluoroscopy screen 120. When such markings
122a and 122b are viewed from the right side RS of the catheter
body the rotational marking indicia 200 will appear as the letter
"R". However, when the catheter is rotated 180.degree. such that
the fluoroscope 118 views the catheter from the left side LS of the
catheter body, the rotational marking indicia 200 will appear as
the inverted mirror image of the letter "R", thereby informing the
operator that the catheter is rotated 180.degree. from the desired
rotational orientation.
[0141] FIG. 6b shows a similar marking scheme wherein the
rotational marking indicia 200 is formed adjacent a radio-opaque
circle 24 formed on the right side RS of the catheter body such
that, when the catheter body is in its desired rotational position,
a radio-opaque dot 126 formed on the left side LS of the catheter
body will appear within the circle 124 on the fluoroscopy screen
120, and the rotational marking indicia 200 will appear as the
letter "R" to the right of the radio-opaque circle 124. However,
when the catheter body is rotated 180.degree. such that the
fluoroscope 118 is viewing the left side LS of the catheter body,
the rotational marking indicia 200 will appear as the inverted
mirror image of the letter "R" on the left side of the circular
marking indicia 124, as illustrated in FIG. 6b.
[0142] Similarly, as shown in FIG. 6c, the catheter 100 may be
provided with two (2) through holes 128a, 128b formed in direct
linear alignment with one another on opposite sides of the catheter
100. Adjacent one of the through holes is an imageable marker in
the form of the letter "R". When the catheter 100 is rotated such
that the through holes 128a, 128b are in direct alignment with the
extracorporeal imaging apparatus 118, both through holes 128a, 128b
will appear as a single aperture on the image provided on the image
viewing apparatus 120. However, when the through holes 128a, 128b
are not in direct alignment with one another, they will appear as
separate images on the image viewing apparatus 120. In this manner,
these through holes 128a, 128b may be utilized to discern the
correct rotational orientation of the catheter using an
extracorporeal imaging apparatus 118. Similarly, as described
hereabove, the letter R will appear differently depending on which
side of the catheter 100 is closest to the imaging apparatus 118,
thereby avoiding any possible inadvertent 180.degree. mis-rotation
of the catheter.
[0143] vi. Apparatus For Preventing Inadvertent Deployment of
Tissue Penetrating Element
[0144] FIG. 8 shows another embodiment of the catheter 100e which
incorporates apparatus for preventing inadvertent deployment of the
tissue-penetrating element 150. In this catheter 100e, a lumen
closure member 548 is pivotally mounted on one side of the working
lumen 302 through which the tissue penetrating element 150 will
pass such that, when in an upwardly pivoted position, such member
548 will block the lumen and prevent inadvertent advancement of the
tissue penetrating element out of the opening 134. A balloon 544 or
other pressure exerting member is mounted within the body of the
catheter 100e, adjacent the blocking member 548 in the embodiment
shown, a balloon inflation lumen 546 extends through the catheter
to permit alternate inflation and deflation of the balloon. In this
manner, when the balloon 544 is inflated, as shown in FIG. 8, the
member 548 will pivot upwardly so as to block the working lumen 302
in a manner which will prevent inadvertent deployment of the tissue
penetrating element 150. Alternately, when the balloon 544 is
deflated, the member 548 will pivot downwardly thereby restoring
the working lumen 302 to an open configuration through which the
tissue-penetrating element 150 may pass.
[0145] FIG. 8' shows another embodiment of the catheter 100e which
incorporates apparatus for stabilizing the catheter within a vessel
after proper orientation has been confirmed. This apparatus also
prevents inadvertent deployment of the tissue penetrating element
150 in combination with the stabilization. In this catheter 100e, a
lumen closure member 548' is pivotally mounted near the working
lumen 302 through which the tissue penetrating element 150 will
pass. The lumen closure member 548' is biased or spring loaded by
spring member 998 such that when the balloon, 544' or other
pressure exerting member is deflated, lumen 302 is blocked
preventing inadvertent advancement of the tissue penetrating
element out of the opening 134. A balloon inflation lumen 546
extends through the catheter to permit alternate inflation and
deflation of the balloon. After proper orientation of the catheter
100e has been confirmed, the balloon is inflated which causes a
portion of the balloon to exit the side of the catheter through
exit port 999 which secures the catheter in place within the
vessel, 997 as is shown in FIG. 8''. Simultaneous with anchoring
the catheter in place, inflation of the balloon causes lumen
closure member 548' to pivot thereby opening the working lumen 302
to allow advancement of the tissue penetrating element 150.
[0146] Materials, construction and treatments of the balloon, 544'
may be made to prevent undesired movement or dislodgment in the
vessel during its inflated state. Treatment may include surface
modification, Dacron, or other means.
[0147] It should be appreciated that the general concept of
combining an anchoring device which is deployed after confirmation
of proper orientation of the tissue penetrating element which
simultaneously or nearly thereafter, removes a safety device
previously in place to prevent inadvertent advancement of the
tissue penetrating element, can be accomplished in other ways not
completely described above.
[0148] It will be appreciated by those skilled in the art that the
invention has been described hereabove with reference to certain
presently preferred embodiments and examples only, and no effort
has been made to exhaustively describe all possible embodiments and
examples in which the invention may take physical form.
Furthermore, it will be appreciated that each of the specific
components and elements of the above-described embodiments and
examples may be combined or used in conjunction with any of the
other components shown in relation to other embodiments or
examples, to the extent such recombination of elements or
components may be accomplished without rendering the device,
apparatus, or system unusable for its intended purpose.
Furthermore, various additions, deletions, modifications, and
alterations may be made to the above-described embodiments and
examples without departing from the intended spirit and scope of
the invention. Accordingly it is intended that all such variations,
recombination, additions, deletions and modifications be included
within the scope of the following claims.
* * * * *